Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers

NCT ID: NCT03683680

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2030-10-01

Brief Summary

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This research study is evaluating a new method for determining stage and prognosis of individuals with malignant pleural mesothelioma.

Detailed Description

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The purpose of this research study is to test a new method for determining the stage and prognosis of patients with malignant pleural mesothelioma. Currently, it is not possible to accurately determine cancer stage prior to surgery or another treatment. This new method may allow doctors to better classify cancer stage and give a better estimate for prognosis prior to surgery or another treatment.

In this research study, the investigators would like to use biopsied tissue to study certain characteristics that will help test the new method for determining cancer stage and estimating prognosis.

In this research study, the investigators are...

* Obtaining pleural specimens at the time of routine diagnostic biopsy during the participant's standard treatment.
* Storing your biopsied tissue
* Studying the tissue to determine if the new method of staging and prognosis is accurate and valid

Conditions

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Mesothelioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRiS

* The specimens to be collected will include at least five pleural biopsy samples
* MPT test and the CLDN15/VIM test will be performed

Group Type EXPERIMENTAL

MPT Test

Intervention Type OTHER

molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms

CLDN15/VIM Test

Intervention Type OTHER

molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms

Interventions

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MPT Test

molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms

Intervention Type OTHER

CLDN15/VIM Test

molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All adult patients with a diagnosis of malignant pleural mesothelioma undergoing

* diagnostic pleural biopsy
* pleuroscopy
* and/or VATS resections
* Participants must be 18 years of age or older.

Exclusion Criteria

-Any patient who is found to be unsuitable for

* surgery,
* treatment
* diagnosis,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Raphael Bueno, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raphael Bueno, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Raphael Bueno, MD

Role: CONTACT

617-732-5690

Facility Contacts

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Raphael Bueno, MD

Role: primary

617-732-5690

Other Identifiers

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CA120528

Identifier Type: OTHER

Identifier Source: secondary_id

18-220

Identifier Type: -

Identifier Source: org_study_id

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